Search results for " system"
Article
Biopharma in 2015: A Year for Approvals and Innovations
…nal antibody
Highly efficient inoculum propagation in perfusion culture using WAVE Bioreactor™ systems
The Use of Dynamic Control in Periodic Counter-Current Chromatography
Purification Str…
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology
FDA stated the purpose of the initiative was to “encourage the implementation of a modern, risk-based pharmaceutical quality assessment system.”
In 2004, the agency released an additional guidance…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
These range from better analytical testing and product release services to better operations staff training, optimized media and improved existing quality management systems. Better process developmen…
Article
Selecting a Comprehensive Bioburden Reduction Plan
…n levels, selection of monitoring and detection methods, operator training requirements, and quality system oversight.
BioPharm: What procedure is used to identify the various points in which bio…
Article
Host-Cell Protein Measurement and Control
The European Medicines Agency (EMA) guideline CPMP/BWP/382/97 states, “In summary, for HCP, whatever the product and production system, residual HCP have to be tested for on a routine basis”…“As such,…
Article
A Bright Future for the Plasma Fractionation Industry
There is still a very bright future for the plasma fractionation industry. That was one of the conclusions reached when the 9th Plasma Product Biotechnology (PPB) meeting ended on the beautiful isla…
Article
Biomanufacturing Outsourcing Globalization Continues
As quality systems improve, these emerging regions will take on an increasingly important role on the global biopharma stage.
Recent headlines are testament to growth in China. For example, Cytiva…
Article
Ensuring the Quality of Biologicals
reference standard to demonstrate system suitability, and users are requested to establish their own in-house reference preparation for glycan analysis.
Biosimilars
A similar biological or bio…
Article
Vaccine Development and Production Challenges Manufacturers
Most at risk are infants too young to be vaccinated, children with illnesses that compromise their immune systems, and a broader population that looses immunity over time.
Combating Ebola
Meanwh…
Article
Tackling Analytical Method Development for ADCs
…onding ADC with a different architecture are also issues that must be considered when evaluating the systemic exposure of ADCs as part of drug pharmacodynamic and pharmacokinetic analyses, according …